FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

FDA Warns Clarithromycin May Cause Early Death in Heart Disease Patients

Feb. 28, 2018

The FDA advised prescribers to exercise caution before prescribing clarithromycin to patients with heart disease, saying the antibiotic, sold by Abbvie under the brand name Biaxin and indicated to treat infections, can potentially increase the risk of heart problems or death years later among heart failure patients.

The agency based its recommendation on a 10-year follow-up study of coronary heart disease patients from a large clinical trial.

In the trial, researchers observed an unexpected increase in deaths among coronary heart disease patients receiving a two-week course of clarithromycin that did not become apparent for at least a year.

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